Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165828
Recruitment Status : Terminated
First Posted : September 14, 2005
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai GmbH )

Brief Summary:
Patients with focal epileptic seizures with or without generalization who are at present treated with one or two antiepileptic drugs are eligible for this study, provided that they fulfill all inclusion criteria and none of the exclusion criteria. Following a baseline phase of 8 weeks duration, the patients are randomised and they receive an initial daily dose of 50 mg zonisamide during the first week. The daily dose is then increased to 200 mg zonisamide in group A or 400 mg zonisamide in group B, respectively. After eight weeks of treatment, the daily dose in group A can be increased to 300 mg in case of insufficient efficacy. Control assessments are performed at the beginning of the study and at the end of the prospective baseline phase, if applicable and after 4, 8, 12, and 16 weeks. At the end of the first, second, and third treatment week, and at the end of week six, the patient is additionally contacted by telephone. Efficacy and safety parameters are assessed at baseline, during all control visits, and at the end of the study.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Zonegran Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial to Assess Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
Study Start Date : May 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Zonisamide

Arm Intervention/treatment
Experimental: 1 Drug: Zonegran
Intravenous injection; initial daily dose of 50 mg zonisamide (2x25 mg) in both treatment groups; following a prospective or retrospective baseline phase of 8 weeks the study drug will be administered twice daily during 16 consecutive weeks.

Experimental: 2 Drug: Zonegran
Intravenous injection; initial daily dose of 50 mg zonisamide (2x25 mg) in both treatment groups; following a prospective or retrospective baseline phase of 8 weeks the study drug will be administered twice daily during 16 consecutive weeks.




Primary Outcome Measures :
  1. Change in number of epileptic seizures between week 13 and 16 after start of treatment compared to the correspondently normalized base-line phase. [ Time Frame: 28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria at screening:

  • Adult aged between 18 years and 74 years
  • Focal epileptic seizures with or without secondary generalization
  • Present treatment with one or two antiepileptic drugs (constant dosage during 8 weeks baseline phase prior to initiation of treatment with zonisamide). Stimulation of the vagus nerve is permitted and will not be counted as antiepileptic drug.
  • For women of childbearing potential (postmenopausal for more than 1 year): possible pregnancy during the study can be excluded (by hysterectomy, sterilization or simultaneous application of two recognized methods of contraception (no oral contraceptives only)
  • For male patients with partners of childbearing potential: a safe method of contraception is practiced during their study participation
  • Written consent to participate in the study

Inclusion criteria for randomisation:

  • At least 6 focal or clonicotonic seizures documented completely in a seizure diary or the patient chart during the 8 prospective or retrospective weeks baseline phase.

Exclusion criteria at screening:

  • Epileptic state during the past year
  • Non-epileptic fits
  • Generalized epilepsy
  • More than 4 weeks of seizure freedom during baseline phase
  • Concomitant progressive CNS disease including progressive myoclonus epilepsy
  • Concomitant treatment with vigabatrine and / or topiramate
  • Hepatic and/or renal insufficiency (creatine > 2mg% or GPT > 2 times ULN)
  • Body weight ≤ 40 kg
  • (History of) kidney stones; erythrocyturia, family history (in parents, children, brothers and sisters or grandparents) of kidney stones
  • (History of) drug and/or alcohol dependence
  • Active psychosis
  • Suicide attempt during the past 3 years
  • Pre-treatment with zonisamide
  • Known hypersensitivity to sulfonamides
  • concomitant treatment with neuroleptic drugs
  • pregnant or breast feeding woman
  • participation in another therapy study within 3 months prior to or during this study
  • blood donation planned during or within 4 weeks after the participation in this study
  • elective surgery planned during the participation in this study
  • patient is not willing or not capable to meet the study demands
  • patient does not agree to the forwarding of his/her pseudonymous data
  • patient without legal competence

Exclusion criteria for randomisation:

- More than 4 consecutive weeks of freedom from seizure during baseline phase


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165828


Locations
Show Show 30 study locations
Sponsors and Collaborators
Eisai GmbH
Investigators
Layout table for investigator information
Principal Investigator: Christian Elger Universitatsklinikum Bonn, Klinik fur Epileptologie
Layout table for additonal information
Responsible Party: Eisai GmbH
ClinicalTrials.gov Identifier: NCT00165828    
Other Study ID Numbers: ZNS-D-04-001
2005-000260-57 ( EudraCT Number )
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: November 2013
Keywords provided by Eisai Inc. ( Eisai GmbH ):
Epilepsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Zonisamide
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs